FDA panel recommends approval of Novo Nordisk diabetes drug

FDA panel recommends approval of Novo Nordisk diabetes drug

A U.S. advisory panel on Tuesday recommended approval of a new diabetes drug made by Novo Nordisk A/S that combines two of its existing treatments in a fixed-dose combination designed to be both effective and convenient.

The panel voted 16-0 that the Food and Drug Administration should approve the drug, iDegLira, for patients with type 2 diabetes. The FDA is not obliged to follow the advice of its advisory panels but typically does so.

IDegLira combines Novo Nordisk’s diabetes drug Tresiba, also known as insulin degludec, with its GLP-1 agonist Victoza, or liraglutide. Clinical trials showed the drug helped patients control their blood sugar and did so with one injection rather than two.

On Wednesday, the committee will discuss a similar drug, iGlarLixi, made by Sanofi SA, which combines the company’s experimental GLP-1 agonist lixisenatide with its insulin product Lantus.

The drugs, if approved, would be the first two products with different mechanisms of action in a single, fixed-ratio combination injection. The companies aim to show that treating diabetes earlier and more aggressively will stave off complications from diabetes such as heart disease and blindness.

FDA reviewers said the drug may look more effective in clinical trials than in practice because of the way the trials were designed, adding that greater convenience could come at the price of reduced dosing flexibility. Panelists said the drug’s benefits outweighed those concerns.

“I feel this does bring a new, useful treatment option,” said Dr. Robert Smith, a professor of medicine at Brown University and chairman of the panel.

The panel struggled to precisely define which patients iDeGlira would be most useful for but agreed it would at least be appropriate for patients who were previously taking either insulin or a GLP-1 drug.

There was less clarity about the drug’s usefulness in patients who had not previously taken one of those drugs. Some panel members said they would be reluctant to start a patient on two new drugs at once. But certain patients in this group, such as those who were needle-shy, could benefit, they said.

Dr. Todd Hobbs, U.S. chief medical officer for Novo Nordisk, said the company was “extremely pleased” with the panel’s recommendation. “This is an important milestone for healthcare providers and patients,” he said.

Panel members recommended the agency ensure that the drug’s label makes clear that the injection contains two drugs.

Diabetes affects more than 22 million people in the United States, according to federal data.

(Reporting by Toni Clarke in Washington; Editing by Peter Cooney and Jonathan Oatis)